MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. LONG CLIP

Model Number	HX-610-090L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.Article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
Olympus reviewed the following literature titled "gel immersion endoscopic mucosal resection (emr) for superficial nonampullary duodenal epithelial tumors may reduce procedure time compared with underwater emr (with video)".Literature summary: this retrospective cohort study was aimed to evaluate the endoscopic outcomes of underwater endoscopic mucosal resection (uemr) and gel immersion emr (giemr).Total 23 patients were included in this study.Giemr significantly reduced the procedure time compared with uemr.There was no significant difference between the uemr and giemr groups for en bloc resection rate and r0 resection rate.There was one case of intraoperative bleeding in the giemr group and one in the uemr group; both of which were controlled with endoscopic clips.No serious complications were observed in either group.This study concluded that giemr was safe and had good therapeutic results for snadets and showed the potential to accelerate the procedure time compared with uemr.This method may be particularly useful in areas where immersion in water is difficult.Intraoperative bleeding was defined as bleeding during or immediately after endoscopic resection.Type of adverse events/number of patients [giemr group] (n= 13).Intraoperative bleeding - 1 patient.[uemr group] (n=10).Intraoperative bleeding - 1 patient.The literature described "ez clip", and hx-610-090l was selected since it was shipped most to the area during the study period.This article includes 3 reports: (b)(6)/gif-q260j.(b)(6)/sd-210l-15.(b)(6)/hx-610-090l.This report is 3 of 3 for (b)(6).

• Brand Name: LONG CLIP
• Common Device Name: LONG CLIP
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15501434
• Report Number: 9614641-2022-00378
• Device Sequence Number: 20793156
• Product Code: PKL
• UDI-Device Identifier: 04953170200373
• UDI-Public: 04953170200373
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HX-610-090L
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2022
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK SERIAL/LOT: GIF-Q260J, SD-210L-15
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown